Sr. Regional Pharmacovigilance Officer
Year Thane, Maharashtra, India
Job Description
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At Bayer we\xe2\x80\x99re visionaries, driven to solve the world\xe2\x80\x99s toughest challenges and striving for a world where ,Health for all, Hunger for none\xe2\x80\x99 is no longer a dream, but a real possibility. We\xe2\x80\x99re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining \xe2\x80\x98impossible\xe2\x80\x99. There are so many reasons to join us. If you\xe2\x80\x99re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there\xe2\x80\x99s only one choice.
Sr. Regional Pharmacovigilance Officer
POSITION PURPOSE: The Regional PV Officer (Senior) position belongs to the PV Regional Center. The Regional PV Officer (Senior) contributes to assure patients\xe2\x80\x99 safety by complying with all PV Quality System Documents (QSDs) and local and international regulatory requirements. The main purpose of the position is to ensure that Bayer Pharmacovigilance (PV) standards are met by performing and bringing expertise in case management and PV process management activities.
YOUR TASKS AND RESPONSIBILITIES:
- Supports the PV Regional Center Manager on keeping oversight of the activities and tasks handled by external service suppliers.
- Supports the Local PV teams serving as functional support for source document handling / source document upload in SDRA during absences. Additional country specific tasks can be also covered depending on local situation.
- Tasks may include one or a combination of the two areas listed below:
PV Case Management:
Executes all matters regarding PV cases/Product Technical Complaint (PTC) handling relating (but not limited) to:
- PV case receipt and transfer to Argus where applicable. Identification of PV cases where missing or unclear information is provided and performs clarification as needed.
- Case follow up and action item handling activities.
- Coordination of translation of PV case source documents.
- Liaises with the Country Quality Function in relation to PV cases associated with PTCs and aligns on actions, if required.
- PV case reconciliation with internal and external partners.
- Reporting of PV cases to Health Authorities, Investigators and Ethics Committees where applicable.
PV Process Management:
Executes a high-quality oversight of PV process, improves processes and compliance management by:
- QSD management.
- Assisting local PV CAPA management.
- Supporting preparation, roll-out and conduct or assignment of PV trainings to local organizations and external vendors/partners.
- Supporting local Pharmacovigilance Contract Management.
- Inspection and audit preparation in collaboration with local PV teams and global inspection management.
- Generating local Pharmacovigilance System Master Files.
- Supports the mentoring of junior team members in the day-to-day operational activities, as applicable.
WHO YOU ARE:
- Scientific degree related to the area, with 3-5 years\xe2\x80\x99 experience in the Pharmaceutical industry, preferably in Pharmacovigilance
- Experience in leading functional teams in an international and multi-country setting
- Mentoring team members within the PVRC
- Excellent English language (written and verbal communication)
- Team worker, able to work under tight timelines
- Good communication skills
- Excellent organizational skills with the ability to find solutions (technical and non-technical) in a complex environment
- Ability to follow and adhere to procedures and to make process improvement proposals
- Independent problem solving skills
- Knowledge of major concepts in data management and systems
- Core Bayer competencies relevant for the position:
- Manages complexity
- Plans and aligns
- Drives results
- Instills trust
YOUR APPLICATION
Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.
Location:
India : Maharashtra : Thane
Division:
Pharmaceuticals
Reference Code:
819525
Contact Us
+ 022-25311234
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Job Detail
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Job IdJD3341056
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationThane, Maharashtra, India
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EducationNot mentioned
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ExperienceYear